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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04533191
Other study ID # IIT-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date February 1, 2021

Study information

Verified date May 2024
Source Vance Thompson Vision
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria: 1. Patients able to sign informed consent 2. Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation. Exclusion Criteria: - Inability to sign informed consent - Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA - Unable to return for light treatments

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
LAL IOL lens
Standard of care Cataract surgery with IOL placement

Locations

Country Name City State
United States Vance Thompson Vision Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Vance Thompson Vision

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Binocular uncorrected distance, intermediate, and near visual acuity Through Month one post-op
Primary Binocular uncorrected depth of focus Through Month one post-op
Secondary Manifest refraction Through Month one post-op
Secondary Monocular uncorrected distance visual acuity Through Month one post-op
Secondary Monocular best corrected distance visual acuity Through Month one post-op
Secondary Visual Satisfaction Visual satisfaction will be obtained using a visual questionnaire Through Month one post-op
Secondary 4th order total eye spherical aberration (Z12) Through Month one post-op
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